Abstract
The COVID-19 pandemic has been a public health emergency on a global scale, impacting all nations and peoples. As previous health emergencies demonstrated, even when the infectious agent is nonselective, people and contexts are affected differently. Frequently these differences are not due to individual characteristics but to precarious contexts that became even less safe during emergencies, and exacerbate inequalities. An unknown disease that affects the world in a rapid manner brings many challenges. These range from an initial lack of knowledge about the biological effects of the viral infection and how to treat it, to its impacts on resources and economies. Inequitable COVID-19 vaccine distribution can be understood as a categorical example of how the pandemic has had different impacts on different countries and populations, and has exacerbated vulnerabilities. The importance of a comprehensive and considered account of vulnerability in research ethics has been discussed for decades, and this chapter provides an overview of the concept of vulnerability by outlining three dimensions of vulnerability discussed in the literature: the individual, the structural and the relational. These dimensions can overlap and intersect in dynamic and relational ways, especially during public health emergencies such as the COVID-19 pandemic, highlighting the importance of paying attention to vulnerability and inclusion in research, and to the development of protections that account for vulnerabilities in research. The cases presented in this chapter provide examples of how the COVID-19 pandemic exacerbates pre-existing vulnerabilities and show why it is important to reflect on this. Specifically, they prompt consideration of ethical issues associated with excluding populations such as pregnant women and people with disabilities from research, conducting research with psychiatric patients, and conducting research in impoverished settings with heighted food insecurity during the COVID-19 pandemic.
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Keywords
- COVID-19 pandemic
- Research ethics
- Public health emergencies
- Vulnerability and inclusion
- Risk/benefit analysis
- Social and scientific value
- Safety and participant protection
- Research design and adaption
- Researcher roles and responsibilities
- Privacy and confidentiality
- Data protection, access and sharing
- Boundaries between research, surveillance and clinical care
- Digital and remote healthcare and research
- Resource allocation
- Community engagement and participatory processes
8.1 Introduction
The COVID-19 pandemic has been a public health emergency (PHE) on a global scale, impacting all nations and peoples. As is already known from previous health emergencies, even when the pathological agent is nonselective, different people and countries are affected differently. Frequently these differences are not due to individual characteristics but to precarious contexts that became even less safe than before (Khetan et al. 2022). An unknown disease that affects the world in a rapid manner brings many challenges. These range from an initial lack of knowledge about the biological effects of the viral infection and how to treat it, to its impacts on resources and economies. Inequitable COVID-19 vaccine distribution can be understood as a categorical example of how the pandemic has had different impacts on different countries and populations, and has exacerbated vulnerabilities (Acharya et al. 2021; VOA News 2021; Basak et al. 2022; Fisseha et al. 2021).
The importance of a comprehensive and considered account of vulnerability in research ethics has been discussed for decades (Luna 2009, 2019; Hurst 2008; Lange et al. 2013). In order to provide an overview of the concept of vulnerability, we will examine at least three dimensions of vulnerability discussed in the literature: the individual, the structural and the relational. We will also show how these dimensions can overlap and intersect in dynamic and relational ways, especially during PHEs, such as the COVID-19 pandemic (Luna 2009, 2019; The Lancet 2020). The cases presented in this chapter provide examples of how the COVID-19 pandemic exacerbates pre-existing vulnerabilities and show why it is important to reflect on this. Clearly, there is an ethical imperative for research data to reflect the needs of the most vulnerable populations.
Economic and political instability, along with insufficient medical and social protection resources, have been important drivers of the worsening inequities and inequalities seen during the COVID-19 pandemic (Rocha et al. 2021; Etienne 2022; Busso and Messina 2020). The widening of social, racial, gender and economic inequalities worsens existing vulnerabilities and creates new ones. In this context, ethical issues must be carefully considered when research is carried out with populations who face historical and socio-economic structural inequalities. These considerations also affect how we should think about research ethics during PHEs with populations in disadvantaged contexts. The exclusion of groups or individuals as research participants is an approach that in many instances leads to the worsening of vulnerabilities, and inclusion strategies should always be adopted.
8.2 Conceptualizations of Vulnerability
On the individual level, the idea of vulnerability is related to the postulation that every individual has fragilities requiring safeguards (Butler 2010, 2016). Precariousness is understood as a condition shared by all living beings, owing to our dependence on contexts and our interdependence with each other, which has been defined as the “inherent source of vulnerability” (Lange et al. 2013; Butler 2010). As such, precariousness, or our inherent vulnerability, can be seen as an equalizing generalized condition of human beings. Yet, in certain situations where populations face structural determinants of inequality, this omnipresent condition of fragility is experienced differently.
Case 8.1 prompts reflection on the exclusion of pregnant women from clinical trials for the COVID-19 vaccine. The discussion of vulnerability proves essential when thinking about research ethics in this situation for at least two reasons. Against a background of gender inequity and the historical relativization of women’s autonomy during pregnancy, important questions arise about when pregnant women are not offered the opportunity to make an informed decision about participation in vaccine trials for an emerging disease. At the start of the COVID-19 pandemic pregnant women were deemed too vulnerable to participate in vaccine trials, though not vulnerable enough to the effects of the virus to receive the vaccine during initial vaccine rollouts.
Pregnant women should not be considered vulnerable simply by virtue of being pregnant (CIOMS 2016). The consequences of an initial categorical exclusion from vaccine research were dramatic for pregnant women in the most precarious contexts. COVID-19 was found to be associated with an increased risk of maternal morbidity and mortality (Metz et al. 2022). Many countries in the global South had rates of maternal mortality due to COVID-19 five to ten times higher than those in countries in the global North (PAHO and WHO 2021). Most of the pregnant women hospitalized with COVID-19 were unvaccinated (Engjom et al. 2022). The assumption that a category of people (pregnant women) should be excluded from research trials on the basis of pre-existing vulnerabilities becomes fundamentally flawed when it creates and worsens vulnerabilities. It can be argued that evidence suggests that this exclusion from COVID-19 vaccine trials led, at least in some part, to harm, not protection, for pregnant women and exemplifies how, in research, vulnerabilities should guide our focus, not avert it.
Vulnerability also has structural dimensions; that is, there are economic, social and cultural dynamics that create power differentials (Palk et al. 2020). Contexts of inequality and inequity produce conditions for deprivation and oppression of certain individuals, groups or populations (Butler 2016; Malmqvist 2017). Researchers and bioethicists commonly describe individuals or groups who face structural social and health inequalities as vulnerable, as seen in the Helsinki Declaration (World Medical Association 2013). Initial ideas of vulnerability were mostly categorical – e.g. pregnant individuals (Case 8.1), psychiatric populations (Case 8.2) or extremely poor people (Case 8.3). Although the categorical understanding of vulnerability has been an important step towards trying to solve issues of vulnerability in research, it carries limitations.
Cases 8.1–8.4 in this chapter illustrate how a lack of social protection and public services, impoverishment, social and gender inequalities, disabilities, racism and discrimination compound the many other factors that expose some populations to “layers of vulnerability”. The concept of “layers of vulnerability”, proposed by Florencia Luna (2009), provides a framework that helps us understand how the different dimensions of vulnerability are connected and how they interact with each other: “The metaphor of a layer gives the idea of something ‘softer’, something that may be multiple and different, and that may be removed layer by layer. It is not ‘a solid and unique vulnerability’ that exhausts the category; there might be different vulnerabilities, different layers operating” (Luna 2009, p. 128). Some layers of vulnerability may have a cascading effect, “which may create further layers of vulnerability or worsen existing ones” (Palk et al. 2020, p. 161). The idea of dimensions that intersect, interact, overlap and affect each other can also aid in the understanding of how these layers create contexts that make people vulnerable and points to the limitations of a categorical approach to vulnerability.
When analysing Cases 8.3 and 8.4, it is important to note that poverty and social exclusion have been defined not only as structural issues, but also as relational and fluid processes that are thought to be “driven by unequal power relationships interacting across an economic, political, social and cultural dimension and operating at different levels, including individual, household, group, community, country and global levels” (Ravinetto et al. 2013). These processes are considered to be important conditions that create vulnerabilities in medical research because they lead to health inequalities and diminished autonomy (Popay 2010). Thus, the relational aspect of vulnerabilities speaks to how these conditions interplay and interact in making someone vulnerable in a specific context. Research is inherently a context that impacts these dimensions, and can, therefore, add layers or trigger a cascade of vulnerabilities. The Nuffield Council on Bioethics and the Council for International Organizations of Medical Sciences (CIOMS) also remark on how vulnerabilities are dependent on the context (CIOMS 2016; Nuffield Council on Bioethics 2015, 2020). This indicates the complexity of vulnerability as far as research processes are concerned, even though its consideration is central to ethical practice.
Case 8.2 gives us the opportunity to reflect on research during the COVID-19 pandemic with groups that have specific needs. As this case shows, face-to-face contact can be essential when interacting with institutionalized or hospitalized psychiatric participants. At the same time, researchers need to be aware that some situations might expose participants to a harmful emerging virus. Researchers must be very careful when assessing situations in which limitations on autonomy are already imposed by structures of power, such as in a psychiatric unit or detention centre. These contexts can demonstrate how structural imposition of restrictions on autonomy can trigger a cascade of vulnerability. Adding a pandemic to this situation should draw scrutiny, as participants might feel inclined to participate in research because of a lack of other visitors or because the staff are paying them less attention. Here we can see how a PHE creates an urgent demand for research on the pandemic’s impact on populations who already live in vulnerable contexts. This highlights the importance of considering how best to care for and address the urgent needs of populations living in residential facilities with restrictions on their freedoms, including prisons and other detention facilities.
The cases presented in this chapter aim to provoke reflection not only on concepts of vulnerability, but also on the necessity of thinking creatively and broadly about how to foster conditions that guarantee an inclusive approach in the research setting while promoting protection for research participants and their communities. In the course of a health emergency, the information produced by scientific inquiry becomes essential – especially as a way of dealing with the emergency itself. However, PHE situations are also known to exacerbate the conditions for increased vulnerabilities or to trigger their layers (Nuffield Council on Bioethics 2020; Kass et al. 2019; Chattu and Yaya 2020). Thus, combining an acknowledgement of vulnerability as an inherent possibility of the human condition (the individual dimension) with a context-sensitive analysis (structural and relational dimensions) can provide a way to reach a broader comprehension of all that is at play when thinking about research participation (Rogers et al. 2012). In particular, the provision of an effective approach to protecting participants during emergencies requires careful analysis of and attention to the individual, structural and relational dimensions of vulnerability.
Case 8.4 exemplifies the absence of people with disabilities from research during the pandemic. The WHO has notified some of the ways people with disabilities can be disproportionally impacted during the COVID-19 outbreak (WHO 2020). The exclusion of people with disabilities from research increases their vulnerabilities and leaves significant knowledge gaps regarding their health, needs and rights. In addition, it is important to recognize that COVID-19 can have long-term effects, including chronic health problems and increased susceptibility to disease. These also disproportionately impact those who live with multiple health disparities (Briggs and Vassall 2021). Disability-inclusive approaches to research should not be restricted to responses during a PHE; research practices should be recognized as making a fundamental contribution to understanding impacts and creating adequate and effective responses. These approaches should not only address the challenges and barriers people with disabilities face but also be undertaken in coordination with beneficiaries and existing sectors in civil society, and with health and social programmes (Banks et al. 2021).
8.3 Vulnerability and Inclusion in Research Ethics
Bioethics principles such as autonomy, beneficence and maleficence represent important ethical values; nevertheless, without careful analysis of the complexities of specific contexts which produce vulnerabilities, these values can become abstract and may result in the application of principles in ways that are not appropriately responsive to the context (Nuffield Council on Bioethics 2020). The recognition of different dimensions of vulnerability also means that understanding of this concept may not be assumed to be self-evident. From this perspective, research procedures may be considered ethically sound by research ethics committees, but perceived differently by a community or by grassroots organizations (Nuffield Council on Bioethics 2020).
Although the need to take vulnerability into account in research studies necessitates protection strategies, the idea of vulnerability has also been used to justify the categorical exclusion of individuals or of whole categories of people from research studies. The systematic exclusion of groups historically labelled as vulnerable, such as those living with food insecurity (Case 8.3), pregnant women (Case 8.1), people with disabilities (Case 8.4) or institutionalized people (Case 8.2) has led to a lack of imagination about who needs care, how to support autonomy and how to provide care for these groups (Dashraath et al. 2020; Stemple et al. 2016; Palk et al. 2020). Exclusion reinforces a lack of reflection and experience amongst researchers and research ethics committees (REC) on how to conduct ethical research with these groups (O’Mathúna and Siriwardhana 2017; Spiegel 2017). The consequences of categorical exclusions in the name of participant protection have deepened the marginalization of certain people and groups, as well as precluding them from enjoying the possible benefits of research participation and hindering scientific advancements of relevance to them.
It is important to consider how to promote the participation of people who have been historically excluded from studies, especially as the need for inclusive approaches is increasingly being recognized (Nuffield Council on Bioethics 2020). Guaranteeing conditions for inclusion and participation has been seen as a central aspect of ethical practice in research (Diniz 2019). Pregnant women, as seen in Case 8.1, are an example of a group that has been traditionally excluded from drug and vaccine trials (Beigi et al. 2021; Krubiner et al. 2021). The exclusion of pregnant women from vaccine trials during the COVID-19 pandemic and the Zika epidemic demonstrates the deficiencies of much decision-making undertaken far from people’s realities, similarly to the negative consequences of categorical exclusions evidenced in the HIV crisis (MacQueen and Auerbach 2018; Treatment Action Group 2021; HIV Prevention Trials Network 2009; Schuklenk 2003).
There is growing evidence attesting to the impact that considering the perspectives and opinions of those in the field can have on creating more inclusive research practices (Diniz 2019; MacQueen and Auerbach 2018). Efforts are needed to create conditions for inclusion and for benefit-sharing processes compatible with participants’ and communities’ world views. In settings where individuals are impacted by political, social or economic inequalities, participant protection procedures should also involve an analysis of the pre-existing layers of vulnerability that can be activated or added to by research participation.
Case 8.3 draws attention to how research in settings where even the most basic needs are not being met creates ethical tensions between the participants’ reality and standard research procedures, which require sensitive and contextually appropriate resolution. This is particularly important when planning or conducting research with populations that live with extreme vulnerabilities and when, as a result, the research might be one of the few opportunities for them to gain information or even professional attention. Case 8.3 also demonstrates how the pandemic disproportionally increased vulnerabilities in populations experiencing historical and structural social, racial, gendered and economic disadvantages. In addition to identifying the factors that influence the impacts of the pandemic, it is also important that research focuses on investigating how to build conditions that will help to develop community-centred solutions for preparedness and response in a PHE (Maxmen 2021).
One way of reimagining ethical participant protection procedures is to listen to and understand people’s stories, biographies and needs, as is often undertaken in qualitative studies (Diniz 2019; Palk et al. 2020). These require not only knowledge of the local context by the researchers and RECs, but also imaginative and creative processes. Qualitative research has shown novel intersectional models for the inclusion of research participants, building of trust, and joint individual or community participation in research design and evaluation (Abramowitz et al. 2015; Pratt et al. 2020; Den Hollander et al. 2018). These approaches have strengthened inclusion and accountability for the community and brought recognition and validity to research protocols.
8.4 Vulnerability and the Promotion of Protection and Accountability
Community-based approaches play an important role in the identification of layers of vulnerability during the design of a research protocol or in the course of conducting the study (WHO 2016). A participatory approach requires research practices that acknowledge the imbalances of power and allow for attitudes and processes that address inequalities using combinations of different strategies (Lee et al. 2008; Diniz and Ambrogi 2017). That is, even the allocation of resources by the global North to the global South can be perceived as ethically questionable when the most urgent needs of communities and individuals are not addressed (Schuklenk 2014). As some layers of vulnerability are not readily evident and might not be identifiable to an outsider, there is an unjustifiable risk that research practices may reproduce or worsen inequalities if these vulnerabilities are not accounted for during research processes.
Consequently, protocols incorporating categorical approaches to exclusion criteria often insufficiently account for vulnerability and provide partial protection at best. In fact, these approaches can add vulnerabilities, limit understanding and narrow the reach of research benefits. As researchers, we find that these processes can also stifle our imagination and limit our ability to think about how to conduct research with populations in the most precarious contexts. There is no set number of layers of vulnerability that can justify categorical exclusions. Categorical exclusions do not afford protection. The issue of vulnerability in research should be addressed by creating ways of inclusion and protection that account for the layers of vulnerability.
Recognition of the circumstances of all those involved in a study can inform and expand understandings regarding research practices. That is not to say that the roles of researchers, participants and other individuals who form part of the research ecosystem should become blurred or confusing. Instead, it points to the need to recognize the value of a multidisciplinary, intersectional and representative approach, and to use imagination and creativity when thinking about appropriate research processes. This requires research practices that acknowledge the inherent imbalances of power and allow for attitudes and processes that seek equity and protection through inclusion.
There is no single answer to the question of how issues of vulnerability and inclusion should be addressed in research ethics. The commitment, however, is an ethical one – identifying and creating conditions that support inclusion and the development of protections that account for vulnerabilities, including in research responses to public health emergencies. For this, people in contexts that place them in the most precarious situations must be at the centre of the discussions about research ethics and global health governance. It is important to shift away from systems and structures that reproduce and perpetuate inequalities through fixed exclusionary approaches to vulnerability in order to create new methods for ensuring research accountability. Horizontal and long-lasting relationships with communities can amplify perspectives and decrease distances between researchers and potential participants and their communities. A commitment to decrease vulnerabilities, improve protection and enhance ethical practices entails developing approaches, alongside local groups and communities, to promote inclusion.
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Appendices
Case 8.1: Should Pregnant Women Be Included in COVID-19 Vaccine Trials?
This case study was written by members of the case study author group.
Keywords
Vulnerability and inclusion; Risk/benefit analysis; Social and scientific value; Safety and participant protection; Placebo control; Vaccines
Health-care personnel are at high risk of contracting COVID-19, particularly those who work in intensive care units or other emergency settings. As the pandemic has progressed, it has become clear that although preventive measures such as physical distancing, universal masking, frequent hand-washing, efficient testing and contact tracing have important roles to play in reducing the spread of infection, they cannot entirely mitigate the spread of the disease nor end the pandemic. Therefore, mass vaccination, as a means of primary prevention, is widely seen as the most promising strategy for managing the pandemic (Society for Maternal-Fetal Medicine 2020).
According to the WHO report on gender equity in the health-care workforce, an analysis covering 104 countries showed that women make up around 70% of this workforce (Boniol et al. 2019). The US Centers for Disease Control and Prevention have stated that pregnancy greatly increases the risk of mortality from COVID-19 (Centers for Disease Control and Prevention 2020). Concerns about the effects of COVID-19 on pregnant women and newborns have placed them in a high-risk group. As data are gathered, there is evidence to show that pregnant women with COVID-19 have a higher chance of giving birth prematurely and that their children tend to be admitted to the neonatal unit (Allotey et al. 2020). Therefore pregnant women would likely benefit from receiving vaccines that minimize the likelihood of being infected with SARS-CoV-2, and the severity of any breakthrough infections which result in COVID-19.
A protocol for a Phase III placebo-controlled trial of an inactivated COVID-19 vaccine to be tested on health-care professionals was presented to a research ethics committee in a Latin American country. A key inclusion criterion was that that participant must be a health care-professional in direct contact with possible or confirmed COVID-19 cases. Important exclusion criteria for females were pregnancy (confirmed by beta-hCG testing), breastfeeding or intent to engage in sexual relations with reproductive intent in the 3 months following vaccination. The main reason for excluding pregnant women from most vaccine trials was to avoid risks to fetal health, as preclinical trials had not included tests of vaccine candidates in pregnant animals.
Questions
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1.
What are the main ethical considerations regarding inclusion or exclusion of pregnant women in vaccine trials during a pandemic?
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2.
Considering that health-care workers are at increased risk of contracting COVID-19, and that two-thirds of these workers are women, should COVID-19 vaccine trials include pregnant health-care workers? Why?
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3.
If pregnant women are included in COVID-19 vaccine trials, what levels of risk are acceptable and justified? What implications do requirements to manage and minimize risks appropriately have for the design and conduct of trials?
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4.
When a research ethics committee reviews a clinical trial for a new vaccine in an accelerated pandemic pathway, are there results from pre-clinical or clinical research (such as studies with pregnant animals) that require special consideration if pregnant women are to be recruited? Why?
References
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Allotey, J., E. Stallings, M. Bonet, M. Yap, S. Chatterjee, T. Kew, et al. 2020. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: Living systematic review and meta-analysis. British Medical Journal 370: m3320.
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Boniol. M., M. McIsaac, L. Xu, T. Wuliji, K. Diallo, and J. Campbell. 2019. Gender equity in the health workforce: Analysis of 104 countries. Geneva: World Health Organization.
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Centers for Disease Control and Prevention. 2020. Pregnancy, breastfeeding, and caring for newborns, December 28. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnancy-breastfeeding.html.
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Society for Maternal-Fetal Medicine. 2020. SARS-CoV-2 vaccination in pregnancy. Statement, December 1. https://s3.amazonaws.com/cdn.smfm.org/media/2591/SMFM_Vaccine_Statement_12-1-20_(final).pdf.
Case 8.2: Ethics and Research Policy in a Forensic Psychiatric Hospital
This case study was written by members of the case study author group.
Keywords
Vulnerability and inclusion; Safety and participant protection; Research design and adaption; Researcher roles and responsibilities; Privacy and confidentiality; Data protection, access and sharing; Risk/benefit analysis; Boundaries between research, surveillance and clinical care; Non COVID-19 research; Digital and remote healthcare and research
Research in forensic psychiatry, the branch of psychiatry concerning the assessment and treatment of offenders with mental health problems in prisons and secure hospitals, is always a challenging subject, owing to the vulnerabilities of psychiatric patients and to broader concerns about public interest. The COVID-19 pandemic has produced ethical challenges for both forensic psychiatry practice and research. Forensic psychiatry research addresses our understanding of mental health disorders and the legal aspects of specific cases, focusing on the relationship between mental illness and criminality. In Europe, there are strict guidelines for the ethical conduct of research in forensic psychiatry hospitals, to ensure that the interests of participants are appropriately protected. Forensic psychiatry hospitals contain a closed community of patients and prisoners with mental health disorders, who take part in many assessment tests. Face-to-face interactions for assessment are important, and the pandemic has prompted consideration of the ethical and legal implications of implementing tele-psychiatry for such assessments.
The COVID-19 pandemic had immediate effects on the quality management and design of research protocols at a forensic psychiatry hospital in Europe, both in terms of timeframes and of results. During the pandemic, health-care and research staff also had less interest in and capacity to conduct research, because of infection-control restrictions and increased workloads. The physical distancing measures implemented to reduce the risk of SARS-CoV-2 transmission among staff and patients led to restrictions on visitors, in-person legal proceedings and movement around the hospital premises. In implementing these measures, health-care staff needed to address an ethical dilemma: should they develop a strict policy concerning the safety of the patients and prisoners in order to reduce SARS-CoV-2 transmission, with consequences for the psychopathology of the patients; or should they develop a policy approach with fewer restrictions but increased risk of SARS-CoV-2 transmission? This choice could also impact the validity of research. A stricter approach would limit face-to-face interactions during assessments and was more likely to alter patients’ psychopathy, potentially biasing research results.
To minimize transmission risks, there was a move to implement a procedure to select patients potentially suitable for online psychotherapy and to provide psychotherapy and psychoanalysis remotely. This approach would enable some care to be provided for some of the patients at greater risk but raised ethical issues. The provision of remote psychotherapy can raise concerns about privacy, confidentiality and data security, and national data protection regulations had implications for when tele-psychiatry could be used. Furthermore, psychotherapy and psychoanalysis both have a strong ethical focus on preserving the patient’s independence and confidentiality. Questions also arose about the effectiveness of remote psychotherapy and psychoanalysis as discussed in the example below.
Most of the follow-up or case report studies at the hospital relied on face-to-face contact with vulnerable patients, such as those with psychoses, schizophrenia or substance-abuse disorders. In one population study, patients with substance-abuse disorders would take part in a follow-up outpatient programme after their discharge from the hospital. The programme was considered to provide a direct benefit to participants, by providing on-going psychotherapy and support, and reducing the likelihood of further criminal action. Such follow-up studies would typically be conducted in confined settings, including ambulances. With infection-control and other measures to promote the safety and well-being of patients as their priority, researchers discussed how their study could continue during the pandemic with the ethics committee of the hospital. The committee decided that face-to-face contact with the outpatients in such confined settings was not acceptable during the pandemic. The researchers agreed but considered that the assessment and psychometric tests could only be effectively conducted in face-to-face interactions; the results of tele-psychiatry interactions were not considered sufficiently precise either for therapeutic or for research purposes. Consequently the researchers decided to explore the possibility of conducting the research with the local committee for substance-abuse disorders. A decision was taken to develop a special isolated outpatient zone in the hospital, where participants would be tested for COVID-19 and could then enter the main hospital building with appropriate security and infection-control measures.
Questions
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1.
How might the ethical issues presented by psychotherapeutic research with psychiatric patients change or be intensified by a pandemic?
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2.
What ethical challenges arise when seeking to protect the interests of small numbers of vulnerable participants during the COVID-19 pandemic while also conducting research addressing their needs?
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3.
How should the anticipated risks and benefits of using online or face-to-face approaches to follow up research in this context be evaluated and how should they inform assessments of the ethics of the research?
Case 8.3: Studying the Impact of COVID-19 on Vulnerable Populations
This case study was written by members of the case study author group.
Keywords
Vulnerability and inclusion; Researcher roles and responsibilities; Resource allocation; Boundaries between research, surveillance and clinical care; Qualitative research; Digital and remote healthcare and research
In March 2020, an African country confirmed its first cases of COVID-19 and introduced measures to curb the spread of the virus. The initial control measures included promoting regular hand-washing and social distancing, and required that schools, religious institutions, offices and shops close, permitting only essential services to continue. A full lockdown was instated, with a ban on the use of all private and public transport, and a night curfew. From June 2020, most offices and shops were allowed to reopen, provided social distancing was observed and hand-washing facilities were available, and face coverings were required in public places. Private and public transport resumed with a limited number of persons per vehicle. Schools, religious institutions, sports facilities, arcades and places of entertainment remained closed until October 2020, then gradually reopened, and closed again from June until July 2021 during a second lockdown. Apart from examination-year students, who were allowed to return to school in October 2020, all other children remained at home between March 2020 and December 2021, and the night curfew remained in place.
The COVID-19 response has had a marked impact on the health and education of vulnerable populations, as well as on their economic situation and their psychosocial well-being (Kansiime et al. 2021). To understand the impact of COVID-19 and the associated public health response on vulnerable populations, researchers in the country collected information from mothers and children from impoverished backgrounds and fishing communities, families of children with disabilities, and young sex workers, all of whom were participating in other on-going research studies. Through phone interviews, the impact study, which started in June 2020, assesses participants’ knowledge of and concerns about COVID-19, the impact of the COVID-19-related public health response on participants’ daily lives, and suggested actions to reduce spread and support participants.
While planning and conducting the impact study, during the first months of the pandemic, the research team encountered several ethical issues. During the first lockdown period, on-going studies were paused by the national regulatory authorities and the review of new research protocols was delayed as organizations adjusted to working in lockdown. This meant that some studies where ancillary care was usually provided to participants during scheduled study visits were unavailable (Kapumba et al. 2021; Kapumba et al. 2022). As soon as the research team was able to start the phone follow-up and COVID-19 impact interviews in June 2020, it was extremely careful about how it presented what the study was doing, to avoid raising expectations or making promises that would make the participants feel let down. The researchers clearly explained the purpose of the study, clarified their institutional links and listened to any concerns, in order to maintain trust. Nevertheless, various problems brought up by participants caused ethical concerns and raised questions about previously clear boundaries between research activities and public health responses. For example, many participants had not earned any income at all during the first lockdown, and some had run out of food. Others were not able to obtain medication for chronic conditions and had started feeling ill but could not get to a health facility as there was a ban on public and private transport. Ethical issues also arose around access to care in cases where a participant presented with COVID-19 symptoms, as services were limited (Singh et al. 2020). Although the government distributed some food, most participants did not receive any. As the lockdown continued, multiple research teams had to decide what kind of support could be offered as part of their duty of care as a research institution. When study participants presented with emergency situations, the research teams responded by organizing modest food and medicine deliveries to participants’ homes. In exceptional cases ambulance services were arranged for critically ill study participants.
Questions
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What responsibilities do research teams have to respond to the pandemic-related emergency health and nutritional needs of participants?
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Should researchers’ responsibilities differ depending on whether or not participants’ needs relate directly to the study question(s) and methods? Why?
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In a pandemic should the responsibilities of researchers and public health responders be different from the boundaries observed in normal times? Why?
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If you were a member of a research ethics committee responsible for reviewing this study, what would you request the study team to do in advance, by way of preparation?
References
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Kansiime, M.K., J.A. Tambo, I. Mugambi, M. Bundi, A. Kara, and C. Owuor. 2021. COVID-19 implications on household income and food security in Kenya and Uganda: Findings from a rapid assessment. World Development, January 137:105199. https://doi.org/10.1016/j.worlddev.2020.105199.
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Kapumba, B.M., N. Desmond, and J. Seeley. 2021. What do we know about ancillary care practices in East and Southern Africa? A systematic review and meta-synthesis. Wellcome Open Research 6:164. https://doi.org/10.12688/wellcomeopenres.16858.1.
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Kapumba, B.M., N. Desmond, and J. Seeley. 2022. A chronological discourse analysis of ancillary care provision in guidance documents for research conduct in the global south. BMC Medical Ethics 23: 51. https://doi.org/10.1186/s12910-022-00789-6.
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Singh, J.A., S.V. Bandewar, E.A. Bukusi. 2020. The impact of the COVID-19 pandemic response on other health research. Bulletin of the World Health Organization, September 1;98(9): 625–631. https://doi.org/10.2471/BLT.20.257485.
Case 8.4: Inclusion of Persons with Disabilities in COVID-19 Research
This case study was written by members of the case study author group.
Keywords
Vulnerability and inclusion; Researcher roles and responsibilities; Social and scientific value; Community engagement and participatory processes; Resource allocation; Digital and remote healthcare and research
There is a high risk that persons with some types of disability are disproportionately impacted by COVID-19, for a variety of reasons. These include existing barriers to health services; disruption to health or rehabilitation services not related to COVID-19; the effects of containment and isolation on mental health; the implications of social distancing and restrictions on movement for people who require support from caregivers; and the disruption to disability-inclusive development programmes. All of these can have an adverse effect on the well-being, participation and economic security of persons with disabilities.
In a sub-Saharan African country, there was evidence that, directly or indirectly, COVID-19 has a more adverse effect on people with disabilities than on those without. An online survey was being conducted by university researchers in collaboration with a local non-governmental organization (NGO) to determine the impact of COVID-19 on access to routine health care among the general population. Participants were purposively recruited through the local NGO. During the process of data collection, the researchers realized that, for unknown reasons, persons with disabilities were not visible in the research. During the whole research journey – from the conceptualization of the idea and the development of the research team, to the partnership development, proposal development and ethics review application – persons with disabilities were not included. The next stages of the research were data analysis, writing up, dissemination, translation into practice and planning future strategies. The research team considered whether to take steps to include persons with disabilities at that stage, and if so, how. The team also wanted to consider how to maintain the quality of the research, ensure the data were comparable and adhere to the terms of research ethics approval. Ensuring that persons with disabilities are represented in such ventures is a matter for which there is advocacy in the country.
If the research team was to add persons with disabilities, this could compromise the coherence of the research and would require the researchers to submit a protocol amendment for review by the ethics committee. In particular, the description of the sample population in the original research proposal did not allow for the inclusion of an additional population identified after the study had started. If such a population were to be included it would require changes in the research to enable reasonable accommodations for people with disabilities, which were most likely not budgeted for. However, the researchers realized that omitting persons with disabilities would mean that the impact of the COVID-19 pandemic on such persons would not be tracked. This was likely to compromise the effectiveness of consequent health policy decisions by the government, because without these data they would not be well placed to introduce sound prevention and mitigation interventions for this part of the community. Also, if this group was omitted, it would have an impact on the future connections between the researchers and the excluded population.
Questions
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Do researchers studying the impacts of the pandemic on access to routine health care have an obligation to ensure that all groups in society are represented in their findings, even if some are more difficult to reach than others? Why?
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Should the research team ensure that persons with disabilities are included in the research? Why?
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How could this research have been inclusive from its inception, respecting the vulnerability of disabled persons?
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Should the research team support the rights of persons with disabilities to equal access to health care during the pandemic, or is this beyond their remit? Why?
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Brito, L., Ambrogi, I. (2024). Dimensions of Vulnerability. In: Bull, S., et al. Research Ethics in Epidemics and Pandemics: A Casebook. Public Health Ethics Analysis, vol 8. Springer, Cham. https://doi.org/10.1007/978-3-031-41804-4_8
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